Artificial Sweeteners in Breast Milk

University of Aarhus

Status: Completed

Conditions: Overweight; Diabetes Mellitus; Breastfeeding

Treatments: Dietary Supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)

Study type: Interventional

Funder types: Other

Identifiers

NCT04578431

AS0063221

Details and patient eligibility

About

This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Above 18 years old
• Able to give consent
• Able to produce enough amounts of breastmilk
• Danish/English speakers
• Pre-pregnancy BMI below 25 (20 subjects)
• Pre-pregnancy BMI above 27 (20 subjects)
• Diabetes type 1 or 2 (20 subjects)

Exclusion criteria

• Under the age of 18 years old
• Unable to give consent
• Unable to produce enough amounts of breastmilk
• Non-Danish/English speakers
• If they have consumed artificial sweeteners 24 hours prior to trial

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Intervention groups

Experimental group

Description:

The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline

Treatment:

Dietary Supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)